2 February 2016

EMA/HMPC/278091/2015
Committee on Herbal Medicinal Products (HMPC)

European Union herbal monograph on Equisetum arvense

L., herba
Initial assessment
Discussion in Working Party on European Union monographs and September 2007
European Union list (MLWP) October 2007
Adoption by Committee on Herbal Medicinal Products (HMPC) for release 31 October 2007
for consultation
End of consultation (deadline for comments). 15 February 2008

Rediscussion in MLWP May 2008

July 2008
Adoption by HMPC 3 July 2008
Monograph (EMEA/HMPC/394894/2007)
AR (EMEA/HMPC/394895/2007)
List of references (EMEA/HMPC/394897/2007)
Overview of comments received during the public consultation
(EMEA/HMPC/230479/2008)
HMPC Opinion (EMEA/HMPC/305044/2008)
First systematic review
Discussion in MLWP May 2015
Adopted by HMPC for release for consultation 7 July 2015
Start of public consultation 27 July 2015
End of consultation (deadline for comments 1). 31 October 2015
Rediscussion in MLWP November 2015
Adoption by HMPC 2 February 2016

Keywords Herbal medicinal products; HMPC; European Union herbal monographs;

traditional use; Equisetum arvense L., herba; Equiseti herba; horsetail herb

1
No comments were received during the period of public consultation. Therefore the final monograph is published together
with the final assessment report and list of references, without an ‘Overview of comments received during the public
consultation’.

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
BG (bulgarski): Полски хвощ, стрък LT (lietuvių kalba): Asiūklių žolė
CS (čeština): přesličková nať LV (latviešu valoda): Kosas laksti
DA (dansk): Padderok MT (Malti): Denb iż-żiemel
DE (Deutsch): Schachtelhalmkraut NL (Nederlands): Heermoes
EL (elliniká): πόα Ιππουρίδος PL (polski): Ziele skrzypu
EN (English): Horsetail herb PT (português): Cavalinha
ES (español): Cola de caballo, partes aéreas de RO (română): iarbă de coada calului
ET (eesti keel): osjaürt SK (slovenčina): Vňať prasličky
FI (suomi): peltokorte SL (slovenščina): zel njivske preslice
FR (français): Prêle (tige de) SV (svenska): Åkerfräken, ört
HR (hrvatski): zelen poljske preslice IS (íslenska):
HU (magyar): mezei zsurló meddő hajtás NO (norsk): Kjerringrokk
IT (italiano): Equiseto (Coda cavallina) parti aeree

European Union herbal monograph on Equisetum arvense L., herba

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European Union herbal monograph on Equisetum arvense L.,
herba

1. Name of the medicinal product

To be specified for the individual finished product.

2. Qualitative and quantitative composition 2,3

Well-established use Traditional use

With regard to the registration application of

Article 16d(1) of Directive 2001/83/EC as
amended

Equisetum arvense L., herba (horsetail herb)

i) Herbal substance
Not applicable.

ii) Herbal preparations

a) Comminuted herbal substance
b) Expressed juice from fresh herbal substance
(DER 1:1.6-2.0)
c) Liquid extract from fresh herbal substance
(DER 1:9), extraction solvent: water
d) Dry extract (DER 4-7:1), extraction solvent:
water
e) Liquid extract (DER 1:5), extraction solvent:
ethanol 96% (V/V) : water : sweet wine
16.5% (V/V) (16.5:13.5:70) (m/m)
f) Liquid extract (DER 1:4.5-5.0), extraction
solvent: sweet wine 16% (V/V):ethanol 96%
(V/V) (91:9) (m/m)
g) Liquid extract (DER 1:1), extraction solvent:
25% ethanol
h) Liquid extract (DER 1:4-5), extraction
solvent: ethanol 31.5% (V/V)
i) Dry extract (DER 7.5-10.5:1), extraction
solvent: ethanol 70% (V/V)

1
The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
The material complies with the Ph. Eur. monograph (ref.: 1825)

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3. Pharmaceutical form
Well-established use Traditional use

Comminuted herbal substance as herbal tea or in

solid dosage forms for oral use.

Herbal preparations in liquid or solid dosage forms

for oral use.

Comminuted herbal substance for decoction

preparation for cutaneous use.

Herbal preparations in liquid dosage forms for

cutaneous use.

The pharmaceutical form should be described by

the European Pharmacopoeia full standard term.

4. Clinical particulars

4.1. Therapeutic indications

Well-established use Traditional use

Indication 1
Traditional herbal medicinal product to increase
the amount of urine to achieve flushing of the
urinary tract as an adjuvant in minor urinary
complaints.

Indication 2
Traditional herbal medicinal product used for
supportive treatment of superficial wounds.

The product is a traditional herbal medicinal

product for use in specified indications exclusively
based upon long-standing use.

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4.2. Posology and method of administration 4

Well-established use Traditional use

Posology

Indication 1
Adolescents, adults and elderly

a) Herbal tea:
single dose: 1-4 g of the comminuted herbal
substance in 150 ml of boiling water as an
infusion or as a decoction (5-15 minutes),
3-4 times daily
daily dose: 3-12 g

Comminuted herbal substances in solid form:

single dose: 500-570 mg
3 times daily
daily dose: 1.5-1.7 g

b) single dose: 10-20 ml, 3 times daily

daily dose: 30-60 ml

c) single dose: 10 ml, 3-4 times daily

daily dose: 30-40 ml

d) single dose: 370 mg 3 times daily or

540 mg 2 times daily
daily dose: 1080-1110 mg

e) single dose: 0.96-1.23 ml, 3-4 times daily

daily dose: 2.88-4.92 ml

f) single dose: 1.1 ml, 3 times daily

daily dose: 3.3 ml

g) single dose: 1-4 ml, 3 times daily

daily dose: 3-12 ml

h) single dose: 0.7 ml, 3 times daily

daily dose: 2.1 ml

i) single dose: 200-225 mg, 3 times daily

daily dose: 600-675 mg

The use in children under 12 years of age is not

recommended (see section 4.4 ‘Special warnings
and precautions for use’).

4
For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

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Well-established use Traditional use

Indication 2
Adolescents, adults and elderly
a) single dose: 10 g of the comminuted herbal
substance in 1 l of water as decoction for
impregnated dressing and irrigation
daily dose: one to several times

b) single dose: 40 ml of the expressed juice in

500 ml water for impregnated dressing and
irrigation
daily dose: one to several times

The use in children under 12 years of age is not

recommended (see section 4.4 ‘Special warnings
and precautions for use’).

Duration of use

Indication 1
Herbal preparations are traditionally used over a
period of 2 to 4 weeks.

Indication 1 and 2
If the symptoms persist longer than 1 week
during the use of the medicinal product, a doctor
or a qualified health care practitioner should be
consulted.

Method of administration

Indication 1
Oral use

Indication 2
Cutaneous use

4.3. Contraindications

Well-established use Traditional use

Hypersensitivity to the active substance.

Indication 1
Conditions where a reduced fluid intake is
recommended (e.g. severe cardiac or renal
diseases).

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4.4. Special warnings and precautions for use

Well-established use Traditional use

The use in children under 12 years of age has not

been established due to lack of adequate data.

Indication 1
If complaints or symptoms such as fever, dysuria,
spasm or blood in urine occur or if the symptoms
worsen during the use of the medicinal product, a
doctor or a qualified health care practitioner
should be consulted.

For preparations other than tea preparations

ensure appropriate fluid intake.

For extracts containing ethanol, the appropriate

labelling for ethanol, taken from the ‘Guideline on
excipients in the label and package leaflet of
medicinal products for human use’, must be
included.

Indication 2
If the symptoms worsen during the use of the
medicinal product, a doctor or a qualified health
care practitioner should be consulted.

If signs of skin infection are observed, a doctor or

a qualified health care practitioner should be
consulted.

4.5. Interactions with other medicinal products and other forms of

interaction

Well-established use Traditional use

None reported.

4.6. Fertility, pregnancy and lactation

Well-established use Traditional use

Indication 1

Safety during pregnancy and lactation has not

been established. In the absence of sufficient
data, the use during pregnancy and lactation is
not recommended.
No fertility data available.

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Well-established use Traditional use

Indication 2

There are no data on use during pregnancy or

lactation. In the absence of sufficient data, the
use during pregnancy is not recommended.
Products containing Equiseti herba should not be
applied to the breast of breastfeeding women.
No fertility data available.

4.7. Effects on ability to drive and use machines

Well-established use Traditional use

No studies on the effect on the ability to drive and

use machines have been performed.

4.8. Undesirable effects

Well-established use Traditional use

Indication 1

Mild gastrointestinal complaints have been

reported. The frequency is not known.

Indication 1 and 2

Allergic reactions (e.g. rash, swelling of the face)

have been reported. The frequency is not known.

If other adverse reactions not mentioned above

occur, a doctor or a qualified health care
practitioner should be consulted.

4.9. Overdose

Well-established use Traditional use

No case of overdose has been reported.

5. Pharmacological properties

5.1. Pharmacodynamic properties

Well-established use Traditional use

Not required as per Article 16c(1)(a)(iii) of

Directive 2001/83/EC as amended.

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5.2. Pharmacokinetic properties

Well-established use Traditional use

Not required as per Article 16c(1)(a)(iii) of

Directive 2001/83/EC as amended.

5.3. Preclinical safety data

Well-established use Traditional use

Not required as per Article 16c(1)(a)(iii) of

Directive 2001/83/EC as amended, unless
necessary for the safe use of the product.

Adequate tests on genotoxicity have not been

performed.

Tests on reproductive toxicity and carcinogenicity

have not been performed.

6. Pharmaceutical particulars
Well-established use Traditional use

Not applicable.

7. Date of compilation/last revision

2 February 2016

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